Simple ObesityNCT06530017
Clinical Trial to Evaluate the Ingested, Space Occupying Hydrogel Capsules for Simple Obesity Treatment
A study testing Ingested, Space Occupying hydrogel capsules in people with Simple Obesity, run by IMEIK Technology Development Co., Ltd. at 10 sites in China.
Trial summary
To evaluate the effectiveness and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Simple Obesity
- What is being tested?
- Ingested, Space Occupying hydrogel capsules
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 10 sitesChina
- Study dates
- 31 Jul 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects have a BMI≥28kg/m²and BMI≤40kg/m²
Who cannot join
- Individuals with secondary obesity, such as hypothyroidism, Cushing's syndrome, etc.
- Those who have undergo surgical method within the past 3 months prior to screening, or plan to lose weight by surgical method during the clinical trial.
- Weight loss exceeding >5% (self-report) within the past 3 months prior to screening.
- Individuals with uncontrolled diabetes mellitus (fasting blood glucose≥7.0mmol/L or glucose loading after 2 hours blood glucose≥11.1mmol/L or glycosylated hemoglobin≥7.0%) .
- Within 1 month before screening or planning to use drugs or health products that may cause significant weight gain or loss during the clinical trials, including biguanides,α-glycosidase inhibitors, SGLT-2 inhibitors, GLP-1 receptor agonists, leptinoid drugs, sympathomimetic drugs, esterase inhibitors, lipolytic injections, sulfonamides, systemic glucocorticoids (more than 1 week), estrogen, thyroid hormones or preparations, antipsychotic or antidepressant drugs, Chinese patent medicines and Chinese herbal medicines, etc.
- Patients with central nervous system diseases (including but not limited to any type of seizures or strokes) and other related neurological diseases or mental illnesses.
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- Those who have suffered or are suffering from swallowing disorders, gastroesophageal reflux disease, gastric or duodenal ulcers, gastroparesis, esophageal and gastric varices, intestinal obstruction or suspected small bowel adhesions, pyloric obstruction, Crohn's disease, ulcerative colitis and other diseases, acute/chronic pancreatitis, as well as a history of gastrointestinal surgery (except those related to appendectomy and intestinal polypectomy), abdominal radiation therapy, and gastrointestinal bleeding.
- Those who have AIDS or a history of cancer within the past 5 years.
- Patients with poorly controlled hypertension, i.e., systolic blood pressure (SBP) > 165mmHg and/or diastolic blood pressure (DBP) >95mmHg.
- Patients with renal insufficiency, i.e., estimated glomerular filtration rate (eGFR<30 ml/min/1.73m2)* calculated by the CKD-EPI creatinine equation as defined by the KDIGO 2012 classification.
- Patients with impaired liver function, that is, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal, or total bilirubin (TBIL) > 3 times the upper limit of normal.
- Those who stop smoking within the past 6 months before the screening period or consider stop smoking during the trial.
- Those who have planned surgery in the past 6 months.
- Pregnant or breastfeeding, planning to become pregnant during the trial (or males unwilling to use an adequate method of contraception), or having a positive pregnancy test result during the screening period.
- Individuals with a history of allergies to cellulose, titanium dioxide, citrate acid and succinic acid.
- Those with severe cardiovascular and cerebrovascular diseases or systemic failure that affects treatment.
- The investigator judges that the subject has other systemic diseases that are not suitable for participating in this trial, and the abnormal laboratory test results are determined by the investigator whether they can be enrolled.
- Participated in clinical trials of other drugs or medical devices within 30 days prior to the screening period.
- Other circumstances that the investigator deems inappropriate to participate in this trial.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100032
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100043
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100071
The Third XiangYa Hospital of Central South University
Changsha, Hunan, 410013
QILU Hospital Of Shandong University
Jinan, Shandong, 250012
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Luoyang, 471003
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110004
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050023
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300070
About this study
Official title: A Prospective, Multicenter, Randomized, Double-blind, Parallel Controlled, and Superiority Clinical Trial to Evaluate the Effectiveness and Safety of Ingested, Space Occupying Hydrogel Capsules for Simple Obesity Treatment
To evaluate the effectiveness and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment
Read the detailed description
Ingested, Space Occupying hydrogel capsules is indicated to aid in simple obesity treatment with a Body Mass Index (BMI) of 28-40 kg/m2，using under the guidance of a physician.This clinical trial seek to evaluate the efficacy and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment.
- Conditions
- Simple Obesity
- Being tested
- Ingested, Space Occupying hydrogel capsules, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingested, Space Occupying hydrogel capsulesDevice
During the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water
placeboDevice
During the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water
| Study group | Role | What they receive |
|---|---|---|
| Subjects in the Study group will be treated with Ingested, Space Occupying hydrogel capsules, which | Experimental | During the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water. Receives: Device: Ingested, Space Occupying hydrogel capsules |
| Subjects in the Placebo group will be treated with placebo of the control medical device. | Placebo comparator | During the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water. Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss percentage from baseline at Week 24
Calculation formula:Weight loss percentage from baseline = (weight at Week 24 after enrollment of subject - baseline weight) / baseline weight×100%
Measured: 24 weeks
Response rate of weight loss at week 24 after enrollment
Calculation formula:Weight loss response rate = Number of subjects with ≥5% weight loss percentage from baseline/total number of subjects ×100%.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start31 Jul 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simple ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IMEIK Technology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peng Li, M.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530017
- Sponsor's protocol ID
- IMK-2023-NK001
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-blind, Parallel Controlled, and Superiority Clinical Trial to Evaluate the Effectiveness and Safety of Ingested, Space Occupying Hydrogel Capsules for Simple Obesity Treatment
- ClinicalTrials.gov ID
- NCT06530017
- Acronym / sponsor ID
- IMK-2023-NK001
- Conditions
- Simple Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- IMEIK Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment
Detailed description
Ingested, Space Occupying hydrogel capsules is indicated to aid in simple obesity treatment with a Body Mass Index (BMI) of 28-40 kg/m2，using under the guidance of a physician.This clinical trial seek to evaluate the efficacy and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects in the Study group will be treated with Ingested, Space Occupying hydrogel capsules, which | Experimental | Device: Ingested, Space Occupying hydrogel capsulesDuring the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water. |
| Subjects in the Placebo group will be treated with placebo of the control medical device. | Placebo comparator | Device: placeboDuring the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The subjects have a BMI≥28kg/m²and BMI≤40kg/m²
Key exclusion criteria (19 listed)
- Individuals with secondary obesity, such as hypothyroidism, Cushing's syndrome, etc.
- Those who have undergo surgical method within the past 3 months prior to screening, or plan to lose weight by surgical method during the clinical trial.
- Weight loss exceeding >5% (self-report) within the past 3 months prior to screening.
- Individuals with uncontrolled diabetes mellitus (fasting blood glucose≥7.0mmol/L or glucose loading after 2 hours blood glucose≥11.1mmol/L or glycosylated hemoglobin≥7.0%) .
- Within 1 month before screening or planning to use drugs or health products that may cause significant weight gain or loss during the clinical trials, including biguanides,α-glycosidase inhibitors, SGLT-2 inhibitors, GLP-1 receptor agonists, leptinoid drugs, sympathomimetic drugs, esterase inhibitors, lipolytic injections, sulfonamides, systemic glucocorticoids (more than 1 week), estrogen, thyroid hormones or preparations, antipsychotic or antidepressant drugs, Chinese patent medicines and Chinese herbal medicines, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingested, Space Occupying hydrogel capsulesDuring the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water | Device | Subjects in the Study group will be treated with Ingested, Space Occupying hydrogel capsules, which |
| placeboDuring the treatment period (24 weeks after enrollment), Subjects should take four (4) capsules (Ingested, Space Occupying hydrogel capsules or placebo) with water every day 10~20 minutes before lunch and dinner, and drink at least 500ml of water | Device | Subjects in the Placebo group will be treated with placebo of the control medical device. |
Primary outcome
Weight loss percentage from baseline at Week 24
Time frame: 24 weeks
Calculation formula:Weight loss percentage from baseline = (weight at Week 24 after enrollment of subject - baseline weight) / baseline weight×100%
Response rate of weight loss at week 24 after enrollment
Time frame: 24 weeks
Calculation formula:Weight loss response rate = Number of subjects with ≥5% weight loss percentage from baseline/total number of subjects ×100%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Li, M.D. principal investigator
Beijing Friendship Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ingested, Space Occupying hydrogel capsules in people with Simple Obesity, run by IMEIK Technology Development Co., Ltd. at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Li (13520464757, liwei@imeik.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss percentage from baseline at Week 24 (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.